69.00€
This course is created to introduce the Regulatory Affairs Department to the unexperienced employee. Course is dedicated to junior specialists or specialists that start their work in pharmaceutical company or in Regulatory Affairs Department and have none or very limited experience in registration process of the medicinal products and maintenance of the medicinal products dossier. It presents the helicopter view of activities that might be required on their position and help to reach a big picture of the regulatory affairs department place in the organization and its internal and external interactions.
After presentation student will be aware of the key concepts related to medicinal product registration, will be able to present regulations and guidelines that are mandatory and very useful in an everyday work in regulatory affairs department. Presentation helps to understand the role of the Regulatory Affairs Department in the organization and shows the complexity of the interactions with external entities involved in medicinal product registration process. During the course student sees useful definitions and industry terms that are specific and unique for the medicinal product registration and pharmaceutical industry.
After this course you will get basic information about:
I am Regulatory Affairs Expert with over 11 years of experience in medicinal products registration and maintaining procedures and with understanding the need for close cooperation with medical, pharmacovigilance, marketing and supply departments. I am looking for new opportunities to expand the knowledge in areas connected with lifecycle of the medicinal product and now I am getting to know the area of Pharmacovigilance with all its curiosities. I am deeply convinced that clear and simple communication is very valuable in learning processes so I prepare courses that are based on my experience and I try to show you all the regulatory affairs secrets that I discovered over the years.
I started my adventure with Regulatory Affairs Department in 2010 as Regulatory Affairs Specialist and each year expanded my experience in:
I hope my courses will be interesting, useful, easy to remember and what is most important understandable to you. Good luck!
Warsaw University of Technology
Department of Chemical and Process Engineering
Master’s Degree, Biotechnology in Industry
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